Status:
COMPLETED
Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzuma...
Detailed Description
OBJECTIVES: * Determine the feasibility of tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autolog...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer, meeting 1 of the following stage criteria:
- Stage IIIB or IIIC disease, meeting both of the following criteria:
- Must have received prior neoadjuvant or adjuvant therapy
- Must have undergone lumpectomy or mastectomy
- Stage IV disease, meeting all of the following criteria:
- Only 1-3 organ sites with disease involvement after induction chemotherapy
- Achieved at least a partial response after induction chemotherapy
- No more than 3 lesions in the organ sites combined
- Inflammatory breast cancer allowed
- Completed chemotherapy, surgery, or radiotherapy for breast cancer within the past 6 months
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 65 and under
- Sex
- Male or female
- Menopausal status
- Not specified
- Performance status
- Karnofsky 80-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- SGOT or SGPT ≤ 2 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
- Renal
- Creatinine ≤ 1.2 mg/dL
- Creatinine clearance ≥ 70 mL/min
- Cardiovascular
- LVEF ≥ 55% by MUGA or echocardiogram
- Pulmonary
- FEV\_1 ≥ 60% of predicted
- DLCO ≥ 60% of the lower limit of predicted value
- Oxygen saturation \> 92% on room air
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No autoimmune disorders
- No immunosuppressive condition
- No other malignancy within the past 5 years
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior biologic therapy except trastuzumab (Herceptin®)
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- No prior radiotherapy to adjacent or involved sites of disease that would preclude study radiotherapy
- Surgery
- See Disease Characteristics
- Other
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00182793
Start Date
July 1 2005
End Date
October 1 2014
Last Update
February 23 2017
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000